Gene Therapy

FUJIFILM Diosynth Biotechnologies is a world-leader in the delivery of microbial, mammalian and viral therapeutics and a global service provider in gene therapy and vaccine production.

Let us be your CDMO partner for life – from pre-clinical, clinical and all the way up to cGMP compliant manufacturing and commercialization. Our services include process development, analytical development and cGMP production.

A gene therapy CDMO partner for life

We have an established team of virologists with deep understanding of viral vectors and virus replication platforms – and extensive experience in the scale-up and GMP production of viral products.

Let us be your CDMO partner for life – from pre-clinical, clinical and all the way up to cGMP compliant manufacturing and commercialization. Our services include process development, analytical development and cGMP production.

Whether you are working to add genes that permit the immune system to recognize diseases, replace mutated genes, or fix them by turning them on or off – we have a solution.

Gene therapy and viral products cGMP production

Gene therapy, viral technology and vaccine production

Gene therapy has the potential to provide more effective treatments and vaccines for a variety of diseases, including cancers, diabetes, hemophilia and AIDS. In addition, gene therapy is particularly relevant in the treatment of rare diseases, because approximately 80% of these orphan diseases are caused by a single gene (monogenic). Several successful clinical studies on viral vector-based gene therapies have been conducted – and an ever-increasing number of products are now entering late-phase clinical trials with the potential of becoming new licensed therapies.

The importance of having a robust and scalable manufacturing process cannot be over emphasized – and this work has to start early for your program to be successful. This is because there are several barriers on the way to commercialization, including finding a good host / virus combination, developing a reliable and efficient process, and then scaling-up that process up for cGMP production.

Our inhouse developed expression platforms – ApolloTM X Mammalian Expression System and pAVEwayTM Microbial Expression Platform – have made us world-leaders in the delivery of microbial, mammalian and viral therapeutics.

Dedicated state-of-the-art cGMP facilities

Two state-of-the-art facilities offer global services based on extensive experience in the scale-up and cGMP production of gene therapy and viral products.

The National Center for Therapeutic Manufacturing which is designed for Process Development and Phase I/II GMP production of gene therapies (Viral, Microbial, Plasmid)

The Flexible BioManufacturing Facility is designed for cGMP production of Viral and Gene Therapy products Phase I-III and Commercial.

Did you know?

That while adeno-associated virus (AAV), adenovirus and lentivirus are some of the most commonly used vectors, Poxvirus and Baculovirus also show great promise? Learn more about the vectors we use at FUJIFILM Diosynth Biotechnologies.

What’s the difference between working with rProteins and Virus/Cells?

There are many considerations to take into account when working with virus/cells as target products instead of recombinant proteins. Virus and cells are alive. The product can be sensitive to chemical attack. Care needs to be taken with agent control. And there are many product challenges like access, format, isolation etc.

Want to learn more about how we at FUJIFILM Diosynth Biotechnologies use our experience to overcome these challenges?